PlainRecalls

2018 Recall Year Insight

Federal agencies issued 7,928 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.59% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 21.7 recalls per day across the FDA, CPSC, USDA FSIS, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 159 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2018.

On this page of 50 records, severity classification shows 1 critical, 47 moderate, and 2 lower-severity recalls. The page references 12 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2018 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Oct 10, 2018

CE18TKPS CONT EPIDURAL TRAY (LF), Material Number 332216 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

EC20C 20G X 100CM CATH CLOSED, Material Number 333540 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 7402322

Smith & Nephew, Inc.

FDA Devices Moderate Oct 10, 2018

SCNB4TK CONT STIM W/4 INCH INSUL TUOHY, Material Number 331756 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

ESPOCAN SPINAL/EPID TRAY W/ 18G TUOHY, Material Number 333193 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149

Smith & Nephew, Inc.

FDA Devices Moderate Oct 10, 2018

CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01

Oridion Medical 1987 Ltd.

FDA Devices Moderate Oct 10, 2018

CE17TKST CONT EPID W/SOFT TIP, Material Number 332082 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

CE17TKFCPS EPIDURAL FULL TRAY, Material Number 332078 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657

Oridion Medical 1987 Ltd.

FDA Devices Moderate Oct 10, 2018

CCE18HK10L CONT EPIDURAL TRAY, Material Number 332264 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

Ultrasonic Bronchoscope BF-UC160F-OL8

Olympus Corporation of the Americas

FDA Devices Moderate Oct 10, 2018

Bronchofiberscope F-1T160

Olympus Corporation of the Americas

FDA Devices Moderate Oct 10, 2018

CE17TKFSDT EPID TRAY W/17GA FIXED WING, Material Number 332093 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Low Oct 10, 2018

smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

Smiths Medical ASD Inc.

FDA Devices Low Oct 10, 2018

smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 10, 2018

CE17TKFCY 17GA SAFETY TUOHY NEEDLE TRAY, Material Number 332075 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Critical Oct 10, 2018

ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75, A28-28/C95, A31-31/C80, A31-31/C100, A34-34/C80, A34-34/C100; Suprarenal Model #/REF: A22-22/C55-O20, A22-22/C75-O20, A22-22/C95-O20, A25-25/C55-O20, A25-25

Endologix

FDA Devices Moderate Oct 10, 2018

Bronchovideoscope F-1TQ180

Olympus Corporation of the Americas

FDA Devices Moderate Oct 10, 2018

CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658

Oridion Medical 1987 Ltd.

FDA Devices Moderate Oct 10, 2018

ES1827QK ESPOCAN COMBINED 27GA, Material Number 333182 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

Bronchovideoscope BF-P240

Olympus Corporation of the Americas

FDA Devices Moderate Oct 10, 2018

VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Varian Medical Systems

FDA Devices Moderate Oct 10, 2018

CE18TKDP CONT EPID/DURAPREP, Material Number 332215 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

CE17TKCDLS CONT EPIDURAL TRAY, Material Number 332212 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

Bronchovideoscope BF-XT160

Olympus Corporation of the Americas

FDA Devices Moderate Oct 10, 2018

OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is i

Johnson & Johnson Surgical Vision Inc

FDA Devices Moderate Oct 10, 2018

Capnostream20 (INTL) M, CS08654

Oridion Medical 1987 Ltd.

FDA Devices Moderate Oct 10, 2018

Capnostream20 (INTL) N REFURBISHED, CS78652

Oridion Medical 1987 Ltd.

FDA Devices Moderate Oct 10, 2018

Bronchofibercope BF-6C240

Olympus Corporation of the Americas

FDA Devices Moderate Oct 10, 2018

CEP18TKO CONT. EPIDURAL PEDIATRIC KIT, Material Number 332290 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

Capnostream20 M NICU (CPM), CS08654RN

Oridion Medical 1987 Ltd.

FDA Devices Moderate Oct 10, 2018

Bronchovideoscope BF-Q180

Olympus Corporation of the Americas

FDA Devices Moderate Oct 10, 2018

ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

Ellex iScience, Inc.

FDA Devices Moderate Oct 10, 2018

ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Moderate Oct 10, 2018

CONT STIM BASIC KIT W/2 IN INSUL TUOHY, Material Number 331757 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

EC20O 20G X 100CM CATH OPEN TIP LF, Material Number 333520 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

Stryker Neurovascular

FDA Devices Moderate Oct 10, 2018

CE17TKF PERIFIX CONTIN. EPIDURAL TRAY, Material Number 332086 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03

Oridion Medical 1987 Ltd.

FDA Devices Moderate Oct 10, 2018

CONTIPLEX TUOHY ULTRA 4 IN CNB400TU, LF, Material Number 331691 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

CONTI ECHO CT W/2IN TUOHY ULTRA 360 SET, Material Number 331767 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

CAPNOSTREAM 20 (INTL) N, Part Number CS08652

Oridion Medical 1987 Ltd.

FDA Devices Moderate Oct 10, 2018

Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

COVIDIEN LLC

FDA Devices Moderate Oct 10, 2018

EC20CS EPIDURAL CATHETER, Material Number 333532 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

CE18TKCD10L 18GA TUOHY/10CC GLAS, Material Number 332217 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

FDA Devices Moderate Oct 10, 2018

CE18T CONT EPIDURAL SET, Material Number 332200 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical, Inc.

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2018 with 2017 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2018

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2018 across the FDA, CPSC, USDA FSIS and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.